First Positive Findings from a Phase III Trial Evaluating
Sublingual-Liquid Ragweed Pollen Extract in North America Presented
at a Featured Poster Session at Prominent Allergy Meeting

SAN ANTONIO--(BUSINESS WIRE)--Feb 25, 2013 - GREER®, a
leading developer and provider of allergy immunotherapy products
and services, announces the release of new data from its pivotal
Phase III investigational clinical trial evaluating the efficacy
and safety of GREER Sublingual (standardized short ragweed
extract) Allergy Immunotherapy Liquid
(SAIL)™, as a treatment for adults with allergic
rhinoconjunctivitis caused by short ragweed pollen. Study findings
were presented during a Featured Poster Session presentation on
Feb. 24, 2013 at the 2013 American Academy of Allergy Asthma &
Immunology (AAAAI) annual meeting in San Antonio, Texas.

Dr. Peter Socrates Creticos, lead investigator of the study,
notes “Millions of Americans suffer from seasonal
allergies. Some patients are treated but not well-controlled on
pharmacotherapy. Our goal in this study was to further evaluate the
safety and tolerability, and define the therapeutic efficacy, of
sublingual immunotherapy with a standardized liquid ragweed
allergen extract as a potential method of treatment for patients
burdened by ragweed-induced allergic rhinoconjunctivitis. We are
pleased that the Academy chose to highlight the study's positive
findings during its featured poster session, thereby allowing us to
reach a large number of our peers in the allergy
community.”

Study Overview

This randomized, multi-center, double-blind, placebo-controlled,
parallel group Phase III trial included 429 participants, ages
18-55 years, across 26 centers in North America. Participants had a
minimum 2-year history of moderate to severe allergic
rhinoconjunctivitis attributable to ragweed pollen that normally
required anti-allergy medications. Participants were randomized to
self-administer a metered dose of SAIL Standardized Short Ragweed
extract or placebo for 8-16 weeks pre-seasonally and during the
entire 2011 ragweed pollen season. The maximum tolerated high dose
was a mean of 50 Amb a 1 units and the low dose was a mean of 18
Amb a 1 units. Study participants maintained daily symptom and
rescue medication electronic diaries.

Study Results

The primary endpoint of the trial was the change from baseline
in average total combined daily rhinoconjunctivitis symptom and
medication scores for the entire pollen season. The intent-to-treat
analysis met its primary endpoint with a 43% reduction in the total
combined (symptom + medication use) score (TCS) relative to placebo
(p=0.0005). Similar results were demonstrated with all secondary
endpoints: TCS during the 3 peak weeks of the short ragweed season
42% reduction compared to placebo (p=0.0007); the average daily
symptom score (DSS) over the entire ragweed pollen season, 42%
reduction vs placebo (p=0.0022) and the average DSS over the 3 peak
weeks of the ragweed pollen season, 41% reduction vs placebo
(p=0.0022). Additionally, 94% of subjects achieved the maximum
tolerated high dose; 3% of subjects remained on the low dose and 3%
of subjects stepped-down from the high dose to the low dose.

Overall, there were no serious adverse events related to study
drug and there was no occurrence of anaphylaxis or use of
epinephrine in the study. Eight serious adverse events occurred in
the study, none judged by the investigators as attributable to
study drug (6 in 3 subjects in the placebo group and 2 in 2
subjects in the SLIT group). Nine participants' study medication
was permanently discontinued for adverse experiences. Of the 9
participants, 6 received active drug. The investigators deemed 2
discontinuations were not related to the study drug and the
remaining discontinuations were for throat/mouth swelling/itching,
difficulty swallowing, and sore throat. The most common adverse
experiences reported in the trial were similar to what has been
found in other SLIT trials, e.g., mild to moderate
oral/throat itching, edema, or swelling, hives or rash and
diarrhea. Researchers concluded that the study provides evidence
that the once-daily administration of SAIL Standardized Short
Ragweed extract was well-tolerated and clinically effective.

“GREER SAIL demonstrated statistically significant and
clinically meaningful results that met the study's
endpoints,” said Terrance C. Coyne, M.D., Chief Medical
Officer at GREER. “This provides further evidence
supporting the potential impact we believe sublingual immunotherapy
may have on treating short ragweed allergies in the U.S. and
Canada.”

“The results from this study are a critical outcome of
our clinical development program for SLIT that we launched seven
years ago,” said John G. Roby, GREER President and CEO.
“GREER is committed to advancing allergy immunotherapy and
we look forward to taking the next steps in the process to gain the
necessary governmental agency approvals for GREER
SAIL.”

About Standardized Short Ragweed Pollen Allergenic
Extract

Standardized short ragweed pollen allergenic extract is
indicated for the skin-test diagnosis of allergy and subcutaneous
immunotherapy treatment of patients with a history of allergy to
short ragweed pollen.

Allergenic extracts can elicit severe adverse reactions
including anaphylaxis, particularly if the initial dosage or rate
of dosage increase is too high. Any person administering a
biological product should be aware of the risk of local or systemic
reactions and be capable of handling such reactions. Patients
receiving subcutaneous allergenic extracts should be kept under
observation a minimum of thirty minutes so that any adverse
reaction can be observed and properly handled.

GREER® SAIL™ is an investigational liquid form of
allergy immunotherapy using the same GREER Standardized Short
Ragweed Extract currently approved for subcutaneous allergy
immunotherapy (SCIT) but administered under the tongue.

About GREER® — In Touch. Within Reach®.

GREER® is a leading developer and provider of allergy
immunotherapy products and services for treating humans and
animals. GREER's clinical development programs are focused on
sublingual allergy immunotherapy liquid (SAIL)™. GREER was
founded in 1904 and is located in Lenoir, North Carolina. For more
information, visit
www.greerlabs.com.

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.